Limited Versus No-limited Shoulder Movement in Breast Cancer Surgery (exercise)

• ClinicalTrials.gov Identifier: NCT03796845
• Recruitment Status: Completed
• First Posted: January 8, 2019
• Last Update Posted: April 7, 2020
• Sponsor: Instituto Nacional de Cancer, Brazil
• Information provided by (Responsible Party): Anke Bergmann, Instituto Nacional de Cancer, Brazil

Study Description

Brief Summary:

Randomized clinical trial that will include women aged 18 or older, submitted a curative surgery for breast cancer at Hospital do Câncer III (HCIII-INCA). Patients will be allocated into two groups: Intervention (upper limbs no-limited movement with amplitude above 90º for flexion and abduction of shoulder) and Control (upper limbs limited movement at maximum 90º amplitude flexion and abduction of shoulder, until withdrawal surgical points). Sociodemographic and clinical data will be collected through interviews, questionnaires and electronic and physical records. The outcomes will be incidence of operative wound complications, like edema, joint restraint, winged scapula, pain, axillary web syndrome through the physical examination, performed by the nursing and physiotherapy team throughout the intervention period, ending in the 30-day post-operatory.

Condition or disease	Intervention/treatment	Phase
Breast Neoplasms	Other: No limited movement after surgery	Not Applicable

Detailed Description:

Breast cancer treatment has been accompanying advances in technology, surgeries are more conservative, however postoperative complications are still observed. At early postoperative period, the most common operative wound complications are seroma, infection and necrosis. Shoulder dysfunctions are a frequent complication and difficult women to return to their activities. There is no consensus regarding the onset and type of exercise in postoperative period. Thus, the objective of this study is to compare the active no-limited mobilization with limited mobilization in the immediate post operatory at the incidence of wound complications in women submitted to surgery for the treatment of breast cancer.

It's a randomized clinical trial that will include women aged 18 years or older, submitted a curative surgery for breast cancer at Hospital do Câncer III (HCIII-INCA) located in Rio de Janeiro. All patients admitted for surgical treatment at the institution and during the study period will be evaluated for eligibility criteria. Those considered eligible for the study will be clarified regarding the objectives, treatment groups, adverse effects and non-compulsory participation of the study. Upon acceptance to participate, they will be allocated to the respective intervention groups. Group 1 - upper limbs no-limited movement with amplitude above 90º for flexion and abduction of shoulder; Group 2 - upper limbs limited movement at maximum 90º amplitude flexion and abduction of shoulder, until withdrawal surgical points.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 465 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients submitted to surgery for breast cancer will be allocated into two groups: Intervention (upper limbs no-limited movement with amplitude above 90º for flexion and abduction of shoulder) and Control (upper limbs limited movement at maximum 90º amplitude flexion and abduction of shoulder, until withdrawal surgical points).
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Limited Versus No-limited Shoulder Movement in Breast Cancer Surgery
• Actual Study Start Date: February 1, 2019
• Actual Primary Completion Date: July 1, 2019
• Actual Study Completion Date: December 20, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: No-limited movement after surgery; Participants should move their arms from the first postoperative day, with unrestricted movement, with an amplitude above 90º for flexion and abduction of shoulder.	Other: No limited movement after surgery; Participants should move their arms from the first postoperative day, with unrestricted movement, with an amplitude above 90º for flexion and abduction of shoulder.
Active Comparator: Limited movement after surgery; Participants should move their arms with restricted movements on the first postoperative day, with maximum amplitude of 90º for flexion and abduction of the shoulder, until withdrawal surgical points. Actual hospital's routine.	Other: No limited movement after surgery; Participants should move their arms from the first postoperative day, with unrestricted movement, with an amplitude above 90º for flexion and abduction of shoulder.

Outcome Measures

Primary Outcome Measures :

1. Presence or absence of wound complications. [ Time Frame: Thirty days of follow-up ]
   Occurrence of wound complications (necrosis, dehiscence, seroma, infection or hematoma) will be obtained by the physical examination, performed routinely by the nursing and physiotherapy during the first month after the surgical procedure.

Secondary Outcome Measures :

1. Measurement of upper limb functionality [ Time Frame: Thirty days of follow-up ]
   Performed routinely by physical therapy using the upper limb functionality questionnaire (Disabilities of the arm, shoulder and hand - DASH) during the first month after the surgical procedure. It is a validated, reliable and translated into Portuguese questionnaire. It has 30 items classified from 1 to 5, and aims to grade physical function and symptoms in people with any upper limb dysfunction. The total score ranges from 0 (no dysfunction) to 100 (severe dysfunction).
2. Measurement of shoulder's range of motion [ Time Frame: Thirty days of follow-up ]
   Performed routinely by the physiotherapist through physical examination of the range of motion of the shoulder during the first month after the surgical procedure.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Women aged 18 and over;
• Indication of curative surgical treatment for breast cancer axillary approach at Hospital do Câncer III / INCA.

Exclusion Criteria:

• Bilateral breast cancer;
• Surgical treatment and / or previous radiotherapy for breast cancer;
• Reconstruction surgery;
• Functional alteration in upper limbs prior to diagnosis of breast cancer;
• Illiterate women who are not able to read and complete the protocol of adhesion;
• Women who are not able to answer questions clearly;
• Age over 80.

Contacts and Locations

Locations

Brazil

Clarice Gomes Chagas Teodozio

Rio de Janeiro, RJ, Brazil, 20230240

Sponsors and Collaborators

Instituto Nacional de Cancer, Brazil

Investigators

• Principal Investigator: Anke Bergmann; CPQ - INCA

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Teodózio CGC, Marchito LO, Fabro EAN, Macedo FO, de Aguiar SS, Thuler LCS, Bergmann A. Shoulder amplitude movement does not influence postoperative wound complications after breast cancer surgery: a randomized clinical trial. Breast Cancer Res Treat. 2020 Nov;184(1):97-105. doi: 10.1007/s10549-020-05826-9. Epub 2020 Aug 17.

• Responsible Party: Anke Bergmann, Principal Investigator, Instituto Nacional de Cancer, Brazil
• ClinicalTrials.gov Identifier: NCT03796845
• Other Study ID Numbers: Shoulder exercise cancer
• First Posted: January 8, 2019
• Last Update Posted: April 7, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Anke Bergmann, Instituto Nacional de Cancer, Brazil:

Exercise

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases